Incontinence treatment device including non-porous sub-urethral sling

ABSTRACT

An incontinence treatment device includes a non-porous sling located between two anchors. A first line is attached between a first end of the sling and the first anchor, and a second line is attached to a second end of the sling and inserted through a channel of the second anchor. The second anchor is provided with a restrictor segment provided in the channel. The second line has an adjustment device attached to the second line and the restrictor segment is configured to resist movement of the adjustment device through the channel. The adjustment device is movable through the channel from a first position that locates the adjustment device between the second anchor and the sling to a second position that locates the second anchor between the adjustment device and the sling to thereby reduce an effective length of the sling between the first and second anchors.

BACKGROUND

Devices for treating urinary incontinence include slings, supports,artificial urinary sphincters and other devices that are implanted in auser to support and/or coapt the urethra.

A sling is a device that is surgically implanted to support the urethraand inhibit urine from undesirably leaking from the urethra. Slings aretypically fabricated from mesh and are implanted through one or moreincisions. The sling is secured to supporting tissue(s) and the tissueeventually grows through the mesh to support the urethra. The surgeonwill peri-operatively determine and achieve the appropriate level oftension in the sling relative to the urethra that will post-operativelyprovide the user with a continent state.

Improved incontinence treatment devices would be welcomed by both thepatient and the surgical staff.

SUMMARY

One aspect provides an incontinence treatment device including anon-porous sub-urethral sling provided with an adjustment device. Thedevice includes a first extension member attached to a first end of thesling, a first anchor attached to the first extension member, and afirst line attached to the first end of the sling and inserted through abore formed through the first anchor. The first line includes a stopdevice fixed to the first line with the first anchor positioned betweenthe stop device and the sling. The device also includes a secondextension member attached to a second end of the sling, a second anchorattached to the second extension member, and a second line attached tothe second end of the sling. The second anchor includes a channel formedthrough the second anchor and a restrictor segment provided in thechannel. The adjustment device is attached to the second line and ismovable through the channel formed through the second anchor. Theresistor segment is configured to resist movement of the adjustmentdevice through the channel.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a perspective view of one embodiment of an incontinencetreatment device provided with an anchor and an adjustment device.

FIG. 2 is a perspective view of the anchor and the adjustment deviceillustrated in FIG. 1.

FIG. 3 is a cross-sectional view of the anchor and the adjustment deviceillustrated in FIG. 1.

FIG. 4A is a schematic view of an incontinence treatment deviceimplanted in the user and configured to allow the passage of urine.

FIG. 4B is a schematic view of the incontinence treatment deviceillustrated in FIG. 4A adjusted to coapt a urethra of the user.

FIG. 5A and FIG. 5B illustrate various adjustment states for theincontinence treatment device illustrated in FIG. 4B.

FIG. 6 is a schematic view of one embodiment of an incontinencetreatment device implanted in a user.

FIG. 7 is a schematic view of one embodiment of an incontinencetreatment device planted in a user.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Tissue includes soft tissue, which includes dermal tissue, sub-dermaltissue, ligaments, tendons, or membranes. As employed in thisspecification, the term “tissue” does not include bone.

In this specification the word “coapt” means to close or tosubstantially close. To coapt an opening is to bring two surfacestogether in close approximation such that the gap between the twosurfaces is reduced or eliminated. To coapt a urethra means tosubstantially yet reversibly close the urethra to impede the passage ofurine and provide a person with a continent state.

In this specification a “user” is one into whom an incontinencetreatment device has been implanted.

In this specification “non-porous” means a material with nothrough-holes. For example, while the non-porous material might includedivots and/or recesses in a surface of the material, the material doesnot have holes that extend through the material from one surface to theother surface. Non-porous, as employed in this specification, thus meansa material that is configured to prevent tissue growth through theimplanted material.

Embodiments provide an incontinence treatment device provided with anon-porous support and an adjustment mechanism attached to the support.The non-porous support discourages or does not allow tissue to growththrough the support such that the support will be able to move relativeto the tissue long after having been implanted. The adjustment mechanismoperates to adjust and move the non-porous support. The adjustmentmechanism moves the support between a first position that allows thepassage of urine and a second position that coapts the urethra. Theadjustment mechanism is provided as an adjustment device thatfrictionally engages with a restrictor segment provided inside of achannel of an anchor. The adjustment device is adapted to be forced pastthe restrictor segment into the second position that is configured totension the support and coapt the urethra.

FIG. 1 is a perspective view of one embodiment of an incontinencetreatment device 20. The incontinence treatment device 20 (device 20)includes a sling 22 or a support 22 provided with tissue anchors 40, 42and an adjustment mechanism 70. The tissue anchors 40, 42 fix the sling22 into place within the pelvis and the adjustment mechanism 70 isaccessible by the user/patient to adjust a position of the sling 22. Thesling 22 is provided as a non-porous material that prevents body tissuefrom growing into or through the sling 22 after implantation. Theadjustment mechanism 70 is operable to move the sling 22 relative totissue to move the sling 22 between a first position that allows thepassage of urine through the urethra and a second position that coaptsthe urethra.

The sling 22 includes a first end 24 and a second end 26. The device 20includes a first extension member 30 attached to the first end 24 and asecond extension member 32 attached to the second end 26 of the support22, a first anchor 40 attached to the first extension member 30 and asecond anchor 42 attached to the second extension member 32, with afirst line 50 inserted through the first anchor 40 and a second line 52inserted through the second anchor 42. The first line 50 is attached tothe first end 24 of the sling 22 and is provided with a stop device 60.The first anchor 40 is positioned between the stop device 60 and thesling 22. The second line 52 is attached to the second end 26 of thesling 22 and is provided with an adjustment device 62. The adjustmentdevice 62 is movable through a channel that is formed in the secondanchor 42 such that the adjustment device 62 and the second anchor 40combine to provide the adjustment mechanism 70.

The sling 22 is configured to be implanted into a user to support theurethra and treat incontinence. In one embodiment of the sling 22 is asub-urethral sling 22 that is implanted under or inferior relative tothe urethra. In one embodiment, each of the first and second anchors 40,42 is fixed in position relative to the sling 22, for example by fixinga length of the first and second extension members 30, 32 and thenconnecting the anchors 40, 42 to a respective one of the members 30, 32.Adjustment of the device 20 is provided by the adjustment mechanism 70.

The adjustment mechanism 70 is operable to move the sling 22 between afirst configuration that allows the user to pass urine and a secondconfiguration that supports and coapts the urethra to provide the userwith a continent state. In one embodiment, the adjustment mechanism 70is user-operable long after the sling 22 has been implanted and thesurgical site has healed. With this in mind, in one embodiment thesub-urethral sling 22 is provided as a non-porous film that is adaptedto reduce or prevent tissue growth through the sling 22, which allowsthe sling 22 to move or slide relative to the tissue after implantation.

The sling 22 is suitably fabricated from polymer materials. For example,in one embodiment the sling 22 is a synthetic material fabricated fromrubber, silicone, thermoplastic polymers, thermoset polymers, or blendsor copolymers of suitable polymers. One suitable sling 22 is molded fromsilicone polymer.

The extension members 30, 32 are secured to the anchors 40, 42,respectively. The extension members 30, 32 and the anchors 40, 42 arefabricated from material that is suited for implantation into the humanbody. Preferably, the extension members 30, 32 and the anchors 40, 42 donot bio-absorb after implantation. As one example, the extension members30, 32 and the anchors 40, 42 are suitably fabricated frompolypropylene.

Each of the anchors 40, 42 is configured to be inserted into and engagedwith tissue. In one embodiment, each anchor is provided with at leastone projection 80 that extends away from a central axis of the anchorand is so configured to engage with tissue. In the illustratedembodiment, each of the anchors 40, 42 includes multiple projections80—or wings—that configure each anchor 40, 42 to engage with tissue whenimplanted.

FIG. 2 is a perspective view and FIG. 3 is a cross-sectional view of oneembodiment of the adjustment mechanism 70. One of the anchors 40, 42,for example in this embodiment the second anchor 42, is provided with achannel 90 that extends between a first end 92 and a second end 94 ofthe anchor 42. The channel 90 is formed to include a restrictor segment96 between the first and second ends 92, 94.

In one embodiment, the second extension member 32 is attached to anexterior surface of the second anchor 42. In one embodiment, the secondextension member 32 is overmolded into a polymer wall of the secondanchor 42.

The second line 52 is inserted through the channel 90 of the secondanchor 42. The adjustment device 62 is sized to have a lateral dimensionthat is larger than a lateral dimension of the restrictor segment 96. Inthis manner, the adjustment device 62 is retained at the first end 92 ofthe anchor 42 when the adjustment mechanism 70 is in a first positionthat allows the user to urinate. The adjustment device 62 is adapted tobe pulled through the restrictor segment 96 when force is applied to thesecond line 52, which pulls the adjustment device 62 from the first end92 to the second end 94 of the anchor 42. The restrictor segment 96 isprovided to maintain the adjustment device 62 adjacent to the second end94 of the anchor 42 until the user applies a restoring force to thesecond line 52, at which point the adjustment device 62 moves backthrough the channel 90 to the first end 92 of the anchor 42. Theselective placement of the adjustment device 62 adjacent to the secondend 94 of the anchor 42 reduces an effective length of the sling 22,which operates to close down the urethra and provide the user with acontinent state.

In one embodiment, the first and second extension members 30, 32 aresecured to each of the respective anchors 40, 42 and these elementscombine to provide the device 20 with a fixation mechanism that isconfigured to secure the sling 22 into tissue when implanted. The sling22, when implanted, is thus suspended on a path having a path lengththat extends between the anchors 40, 42. The first and second lines 50,52 are movable relative to the anchors 40, 42, respectively. In oneembodiment, at least second line 52 is movable through the second anchor42 to shorten the path length of the sling 22, which allows compressionto be applied to the urethra to achieve a continent state as illustratedand described in FIGS. 4A and 4B below.

The lines 50, 52 are fabricated from material that is suited forimplantation into the human body. Preferably, the lines 50, 52 do notbio-absorb after implantation. As one example, the lines are suitablyfabricated from polypropylene.

FIG. 4A is a schematic view of the device 20 as implanted. Whenimplanted, the non-porous structure of the sling 22 will resist andprevent tissue from growing through or attaching to the sling 22.Eventually, a protective pocket of epithelial tissue will grow aroundthe device 20. The non-porous nature of the sling 22 allows portions ofthe device 20 to move within the pocket of tissue that surrounds thesling 22.

During implantation, the first and second anchors 40, 42 are fixed intotissue and the sling 22 is suspended along a path length PL1 thatextends between the anchors 40, 42 under the urethra U. Although theanchors 40, 42 are fixed in the tissue, the non-porous sling 22 is freeto move relative to the tissue. The adjustment mechanism 70 occupies afirst position where the adjustment device 62 is located between thesling 22 and the second anchor 42. In the illustrated first position,the sling 22 is under the urethra U and the urethra U is not coapted,which allows the user to pass urine. The adjustment mechanism 70operates to move the sling 22, which shortens the path length PL1, whichtensions the sling 22 to coapt the urethra U as shown in FIG. 4B.

FIG. 4B is a schematic view of the device 20 with a force F applied tothe second line 52 that is sufficient to draw the adjustment device 62through the anchor 42. With additional reference to FIG. 3, the force Fapplied to the second line 52 pulls the adjustment device 62 through therestrictor segment 96 until the adjustment device 62 is seated on thesecond end 94 of the anchor 42. The selective placement of theadjustment device 62 through the anchor 42 to position the anchor 42between the adjustment device 62 and the sling 22 moves the adjustmentmechanism 70 into a second position that shortens the path length fromPL1 to a shorter path length PL2. The shorter path length PL2 allows thesling 22 to compress and coapt the urethra U. In the illustrated secondposition, the sling 22 is tightened and effectively shortens a distanceof the device 20 between the first and second anchors 40, 42, whichcoapts the urethra U to provide the user with a continent state.

FIGS. 5A and 5B are schematic views of the device 20 with a force Fapplied to the first line 50 (FIG. 5A) to move the adjustment mechanism70 from the second position back to the first position (FIG. 5B) toallow the user to pass urine. For example, the force F applied to thefirst line 50 draws the stop device 60 away from the first anchor 40 andpulls the adjustment device 62 back through the channel 90 (FIG. 3)formed in the anchor 42. In this manner, the adjustment device 62 isonce again located between the sling 22 and the anchor 42, which loosensthe sling 22. Placement of the adjustment device 62 between the sling 22and anchor 42 effectively increases the distance of the device 20between the anchors 40, 42. Increasing the effective distance of thedevice 20 relieves the tension in the sling 22, which relieves theconstriction of the sling 22 against the urethra U to allow the urethraU to open and pass urine.

The incontinence treatment device 20 is implantable into the pelvis ofthe user. The adjustment mechanism 70 operates to allow the user toselect a first configuration of the device 20 that allows urination or asecond configuration that provides the user with a continent state.

In one embodiment, the first line 50 and the second line 52 are directedto a location outside the patient's body (for example through theabdominal wall or through the groin) to allow the user to access andselectively move the adjustment mechanism 70.

In one embodiment, the first line 50 and the second line 52 are directedto a location within the patient's body (for example within the scrotumor the labia) and also operate to provide the user with access to theadjustment mechanism 70.

FIG. 6 is a schematic view of the device 20 implanted within a pelvis Pof a user. In one embodiment, each of the anchors 40, 42 is suitablyimplanted into a membrane of the obturator foramen OF to position thesling 22 under the urethra U. Each of the first and second lines 50, 52are directed through the skin of the patient to a location outside thebody that permits the user to adjust the adjustment mechanism 70 andmove the urethra U between open and closed positions. A suitableantibiotic or barrier at the skin is employed to prevent the migrationof bacteria along the lines 50, 52 into the patient's body.

The device 20 is configured to be implanted into the patient through asingle incision. In one exemplary approach, a single incision is madenear the urethra and tissue is dissected to expose the urethra U. Asuitable introducer tool is employed to direct the first anchor 40 intothe membrane covering the first obturator foramen OF and to permit thefirst line 50 to trail through the skin to a location outside of thebody. A similar introducer tool is employed on the contralateral side ofthe body to place the second anchor 42 into the membrane covering thesecond obturator foramen OF and pass the second line 52 through the skinto a location outside of the body. In one suitable implantationprocedure, the incision is made to expose the urethra (a vaginalincision for a female or a perineal incision for a male) and theintroducer tool is moved from an “outside in” path from the groin,through the membrane over the obturator foramen OF, around thedescending pubic ramus PR, and out of the incision for engagement withthe first line 50 and the first anchor 40. The introducer tool that isnow attached to the first line 50 and the first anchor 40 is pulled backalong its pathway around the descending pubic ramus PR, through theobturator foramen OF, and out of the skin. A similar “outside in” pathis employed on the contralateral side of the body to place the secondline 52 and the second anchor 42.

FIG. 7 is a perspective view of the device 20 implanted in a pelvis P ofthe user with the first and second lines 50, 52 implanted under the skinand in the body of the user. In one embodiment, the anchors 40, 42 aresecured within the tissue covering the obturator foramen OF to suspendthe sling 22 under the urethra U. In one embodiment, each of the firstand second lines 50, 52 is suitably tunneled to a location inside thebody such as within the skin of the scrotum or within the labia of afemale user. It is desirable that the user is able to apply a force theboth the first line 50 and the second line 52. With this in mind, agrasping device 98 is attached to an end of each of the lines 50, 52 toallow the user to apply a pulling force along the lines 50, 52 to movethe adjustment mechanism 70 and open/close the urethra U.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of medical devices asdiscussed herein. Therefore, it is intended that this invention belimited only by the claims and the equivalents thereof.

What is claimed is:
 1. An incontinence treatment device comprising: anon-porous sling; a first anchor; a first line attached to a first endof the non-porous sling and coupled to the first anchor; a second anchorprovided with a channel formed through the second anchor and including arestrictor segment provided in the channel; and a second line attachedto a second end of the non-porous sling and inserted through the channelof the second anchor, the second line including an adjustment deviceattached to the second line; wherein the restrictor segment isconfigured to resist movement of the adjustment device through thechannel; wherein the adjustment device is movable through the channelfrom a first position that locates the adjustment device between thesecond anchor and the non-porous sling to a second position that locatesthe second anchor between the adjustment device and the non-porous slingto thereby reduce an effective length of the non-porous sling betweenthe first and second anchors.
 2. The incontinence treatment device ofclaim 1, wherein the non-porous sling is a sub-urethral sling.
 3. Theincontinence treatment device of claim 1, wherein the first anchor isprovided with a bore formed through the first anchor, and the first lineis inserted through the bore of the first anchor, and further whereinthe first line includes a stop device attached to the first line withthe first anchor positioned between the stop device and the non-poroussling.
 4. The incontinence treatment device of claim 1, furthercomprising: a first extension member attached to the first end of thenon-porous sling with the first anchor attached to the first extensionmember; and a second extension member attached to the second end of thenon-porous sling with the second anchor attached to the second extensionmember.
 5. The incontinence treatment device of claim 1, wherein each ofthe first anchor and the second anchor includes at least one protrusionprojecting outward relative to a central axis of the anchor that isconfigured to engage with tissue.
 6. The incontinence treatment deviceof claim 1, wherein the channel is formed through the second anchorbetween opposed ends of the second anchor and the restrictor segment isprovided in the channel at an approximate midpoint between the opposedends of the second anchor.
 7. The incontinence treatment device of claim1, wherein the second anchor has a first end and a second end, the firstend disposed nearer to the non-porous sling than the second end, and theadjustment device is movable through the channel from the first end tothe second end and the restrictor segment is configured to resistmovement of the adjustment device from the second end to the first endof the second anchor.
 8. The incontinence treatment device of claim 1,wherein the adjustment device is movable through the channel from thesecond position to the first position to thereby loosen the sling byincreasing the effective distance of the device between the first andsecond anchors.
 9. The incontinence treatment device of claim 1, whereineach of the first and second anchors includes at least two tissueengagement wings that configure each anchor for insertion into amembrane covering an obturator foramen of a user.
 10. The incontinencetreatment device of claim 1, wherein the first line is coaxial with thefirst anchor and the second line is coaxial with the second anchor.